Mary Ellen Leciejewski notes that DEHP toxicants can migrate from IV bags to patients.
The use of polyvinyl chloride (PVC) plastic in medical devices and other products has sparked a strong debate in recent years. FDA issued an advisory about the health risks associated with PVC nearly four years ago; however, manufacturers have been slow to switch to new materials. Now, more hospital personnel have become aware of the risks and are calling for safer alternatives. As a result, some manufacturers are taking new steps to provide them.
PVC is a chlorinated plastic that forms dioxin during its production and when burned. The dioxins that are released can be toxic and carcinogenic. However, the hazards linked to PVC in medical devices come from di (2-ethylhexyl) phthalate, or DEHP, the chemical agent used to soften PVC. DEHP can ooze out of the plastic and into solutions that come in contact with the device.
“For the patient, DEHP is now known to be a reproductive toxicant that can migrate in varying degrees—depending on the liquid, storage, and other factors—from the intravenous bags that deliver blood, medication, and fluids to the patient,” says Sister Mary Ellen Leciejewski, ecology coordinator for Catholic Healthcare West (CHW; San Francisco). CHW is a network of 40 hospitals and medical centers located in California, Arizona, and Nevada. As it learned about the physical and environmental effects of products containing PVC and DEHP, CHW began advocating for alternative products from its vendors. Other hospitals have also called for a switch to PVC- and DEHP-free devices.
To address this demand, many manufacturers are now using substitutes for PVC and DEHP. They can be found in products such as catheters, blood bags, exam gloves, and tubing. For example, epidural catheters can be made with nylon or Teflon, and silicone can be used for various types of tubing. B. Braun Medical Inc., B. Braun OEM Division (Bethlehem, PA) went as far as creating an entire line of PVC- and DEHP-free products. It will supply all of CHW's hospitals with PVC- and DEHP-free intravenous (IV) bags and tubing.
“Recently, we have seen a trend among hospitals and medical institutions to convert to PVC- and DEHP-free products,” says Rob Albert, vice president of marketing, pharmaceuticals, and drug delivery at B. Braun Medical. “We believe this may be attributed to the increasing number of clinical studies and the National Toxicology Program Center for the Evaluation of Risks to Human Reproduction data reviews that suggest serious DEHP-related health concerns in specific patient populations.” He suggests that it might also be related to the growing awareness of the potential dangers the products could pose to patients.
DEHP has been shown to cause changes in the reproductive system of male laboratory animals. In 2002, FDA issued an advisory about PVC devices that contain the plasticizer. The agency stated that exposure to DEHP should be limited in developing males. However, it recommended that the risk in not performing a necessary procedure is much greater than the risk connected to DEHP exposure.
A study conducted last year by the Harvard School of Public Health (Boston) found that sick infants receiving intensive therapy with DEHP-containing PVC devices were exposed to excessive levels of the chemical. It estimated that these levels were 25 times higher than those of the general population.
Manufacturers that use PVC products state that environmental issues related to pollutants released during PVC manufacture can be dealt with by participating in proper disposal methods. Many companies stand by the use of PVC, because it has been used for so many lifesaving devices for 40 years.
A list of PVC- and DEHP-free products can be found on the Health Care Without Harm (Arlington, VA) Web site at www.noharm.org/us/pvcdehp/pvcfree.